🇨🇦 Recombinant FVIII in Canada

Recombinant FVIII (Recombinant FVIII) regulatory status in Canada.

Marketing authorisation

Recombinant FVIII in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Recombinant FVIII approved in Canada?

Yes. Health Canada has authorised it.

Who is the marketing authorisation holder for Recombinant FVIII in Canada?

Fondazione Angelo Bianchi Bonomi is the originator. The local marketing authorisation holder may differ — check the official source linked above.